EUCTR2007-006153-31-FR进行中（未招募）1 期
Safety and efficacy of subcutaneous (SC) administration of Clinimix N9G15E in elderly patients at risk for malnutrition, at a dose of 1 liter infused over 12 hours for 7 to 10 consecutive days. A prospective, multicentre, randomized, open-label, non-inferiority, controlled phase III B trial carried out in parallel groups: subcutaneous versus peripheral intravenous administration.
Baxter R and D Europe SCR0 个研究点目标入组 120 人开始时间: 2008年3月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Both genders
- •2. Age superior or equal to 65 years
- •3. Hospitalized and at risk for malnutrition defined by their MNA SF below 12 and GNRI between 83.5 and 97.5.
- •4. Oral intake < 50% of appropriate intake (defined as 30 Kcal/kg/day) for an expected duration of greater than 3 days. Severe dehydrated patients must be rehydrated before enrolling into the trial
- •5. Dated and signed written informed consent, prior to any study-related procedures, provided by the patient or, according to the law (L. 1122-2), by his legal representative or by a personne de confiance” if any written designation or, if not, his family member or, if no family member, a close relative
- •6. Patients in stable condition
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Malnutrition requiring tube feeding or parenteral nutrition when admitted to study. Parenteral nutrition includes use of glucose 10% or greater and amino acid solutions
- •2. Severe cardiac failure or serious cardiovascular compromise
- •3.Patients receiving therapeutic anticoagulation
- •4. Patients with coagulopathies (platelet count < 100,000; Pt or PTT > 1.5 normal)
- •5. Severe burns or other diffuse skin diseases on site of the the infusion administration
- •6. Patient with decubitus ulcers greater than grade 2 (NPUAP classification)
- •7. Patient with an inflammatory syndrome defined by a CRP >50 mg/L
- •8. Severe Renal failure
- •9. Known hypersensitivity to components of Clinimix N9G15E
- •10. Unconsciousness
- •11. Not expected to survive for a minimum of 3 weeks
- •12. Known congenital abnormalities of amino acid metabolism
- •13. Severe uncontrolled hyperglycemia
- •14. Severe electrolyte disorders precluding administration of Na, K, Ca, Mg, PO4
- •15. Patients taking part already in this study
- •16. Patients taking part in any other clinical trials within 2 months
- •17. Patients who have received Clinimix N9G15E or any other amino acid solution within the 10 previous days by any administration routes
- •18. Confined persons and prisoners
- •19. Patients with any other clinically significant disease or clinically significant finding, which, at the discretion of the investigator, would expose the patient to an increased risk of a significant adverse event or would interfere with the assessments of efficacy or safety during the course of the study
- •20.Patients with a history of or physical examination findings indicative of active alcohol or drug abuse
- •21. Known HIV positivity
- •22. Patients without affiliation to the French Sécurité Sociale
研究者
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